Orthodontic appliance

ABSTRACT

An orthodontic appliance  1  for promoting development of a dental arch form in a patient who has an underdeveloped dental arch form is disclosed. The appliance  1  includes an arch-shaped base member  2  that is made of a resiliently flexible material, and a teeth engaging member  5  that encloses at least part of the base member  2 . The teeth engaging member  5  defines upper and/or lower dental arch receiving channels  46, 47  and is made of a resiliently flexible material that is softer than the base member and is deformable. The appliance  1  has a resting form in which the resilient materials of the base member  2  and the teeth engaging member  5  are in their resting condition. The appliance  1  can be flexed or deformed out of the resting form to fit the underdeveloped dental arch form into the dental arch receiving channel  46, 47 . When deformed the appliance  1  exerts a return force that is directed to returning it to its resting form which in use urges the underdeveloped dental arch to expand into a developed dental arch form.

This patent is a continuation-in-part of U.S. application Ser. No.11/787,661, filed 16 Apr. 2007, now abandoned, which was acontinuation-in-part of PCT/AU05/01598, filed on 14 Oct. 2005, whichdesignated the United States, now lapsed, which claimed priority to AU2004 905924 filed on 14 Oct. 2004.

FIELD OF THE INVENTION

This invention relates to an orthodontic appliance for use inorthodontic treatment for developing an underdeveloped arch into adeveloped arch form.

This invention relates particularly but not exclusively to anorthodontic appliance for use in treating a Class 2 malocclusion bypromoting expansion of an underdeveloped upper dental arch. It willtherefore be convenient to hereinafter describe the invention withreference to this example application. However it is to be clearlyunderstood that the invention is capable of broader application. Forexample it can find application in orthodontic treatments other thanthose seeking to expand the patient's arch form. It can also findapplication in the treatment of malocclusions other than class 2malocclusions.

DEFINITIONS

In this specification the term “engaging” shall bear a broad meaning andshall not be limited to a retaining or latching engagement.

In this specification the term “flange” shall bear a broad meaning andshall not be limited to a radially extending wall at the end of acylindrical section. It shall be understood to include a wall or walllike formation that extends transversely away from another surface, e.g.a web surface.

In this specification the term “correct dental occlusion” shall bear abroad meaning and shall refer to an occlusion where the dentition of theupper and the lower arches come together in a correct positioningrelative to each other along the length of the arch.

In this specification the term “dental arch and associated dentalstructures” shall bear a broad meaning and shall include the bone of thedental arch and the surrounding bony gum tissues and soft gum tissues.It shall also be understood to include the dentition on the arch.

BACKGROUND TO THE INVENTION

One type of orthodontic appliance that is known is a custom made plateappliance that is made in a dental laboratory and is moulded from biteimpressions of the dental arches and associated dental structures ofthat particular patient. The bite impressions are used to makelaboratory models of that particular patient's arches and associateddental structures. These models are then used to mould a customisedappliance including a plate that is shaped and configured to becomplementary to that particular user's dental arch and thereby closelyfit that user's dental arch and arch structures.

A limitation of plate appliances is that the cost of producing them ishigh because they are individually made for each patient in a dentallaboratory based on a dental model of the patient and a bite impressionof the patient.

Orthodontic systems using fixed appliances that are commonly calledorthodontic braces are also used for orthodontic treatment. Orthodonticbraces comprise a plurality of brackets each of which is mounted over anindividual tooth and bonded thereto so that it is permanently mounted onthe tooth. The brackets are linked together by means of a wire thatpasses through wire apertures formed in each of the brackets. The wireapplies a force to the brackets that can then reposition and align theteeth on the dental arch.

In particular these fixed appliances can be used to bring the anteriorteeth on the upper and lower arches in the correct relative position toeach other. The wire can progressively be drawn in to retract theincisor teeth on the anterior region of the upper dental arch to “close”an “open” bite.

These fixed appliances using brackets focus on moving teeth on a dentalarch, particularly to align the teeth. For example they can be used toretract protruding teeth, in particular protruding incisors on the upperarch of a user, and they can also be used to advance retruded teeth.

The fixed appliances described above have their drawbacks. FirstlyApplicant's experience is that most orthodontic patients would choosenot to wear braces if an alternative treatment was available. Thebrackets of the braces are generally unsightly and detract from thepatient's looks while the braces are being worn, e.g. for the directionof the treatment. Secondly the braces can be uncomfortable to wear andcan cause trauma, such as cuts and bruises to the intraoral soft tissuesof a user. The soft buccal mucosa is particularly susceptible to injuryfrom projections on the buccal surface of the brackets.

Thirdly the brackets and wire are permanently attached to the dentitionand thus cannot be temporarily removed by a patient in the way that aremovable appliance can be removed. If the braces are particularlyuncomfortable at any point in time to a user they cannot be temporarilyremoved to afford the patient some respite from the discomfort.

Fourthly another problem that has plagued the use of braces is patientrelapse. By this is meant that the teeth tend to move back to theiroriginal positions once the brackets are removed. The braces arepermanent appliances so that when they are removed they cease to haveany influence on teeth positioning. They cannot be used on anintermittent basis to provide a retaining function after the braces havebeen removed in the way that a removable appliance can be used. Thebraces do not offer a realistic or practical option as a retainerappliance once its use as an active appliance to achieve teethrepositioning is completed.

Aside from the traditional orthodontic treatments described above, inmore recent times some treatments have focused on encouraging andpromoting improved myofunctional habits as a way of developing anintraoral environment that is less predisposed to the development ofsevere class 2 and class 3 malocclusions. For example some orthodonticpractitioners have recognised that poor oral habits such as tonguethrusting, incorrect swallowing, and mouth breathing create theconditions in which a malocclusion is likely to develop in a growingchild.

The applicant has developed an arch shaped appliance having a frontregion and two arm regions to train a patient's or user's myofunctionalhabits so that the environment in which arch development and teethpositioning takes place is improved. In particular the appliance cantrain a patient to position certain key intraoral structures such as thetongue in the correct position and thereby resist the development ofmalocclusions that are caused by poor oral habits. One such feature is atongue tab that assists in positioning the tongue at the correct heightand to reduce tongue thrusting. The appliance also correctly positionsthe lower jaw or mandible of the patient relative to the upper jaw ormaxillae. The appliance also encourages the patient to maintain theirlips in a closed position and not to breathe through their mouth.

These appliances are integrally formed of a soft and resilient materialsuch as PVC or silicon rubber. The soft and resilient material enablesthe appliance to be comfortably worn when it bears against the dentalarch and arch structures such as the teeth and gums of a patient.

As the material from which the appliance is formed is soft and flexibleit is easy to deform the appliance to move the arm regions of theappliance towards and away from each other and also to bend and twistthe appliance. The resilience of the material will apply a return forcetending to return the appliance to its original shape when it isdistorted out of its original shape.

In a case where the appliance is deformed to enable it to be fitted ontothe dental arch of a patient, the resilient nature of the appliancematerial may cause the appliance to apply some force to the arch of apatient when it is deformed. However because the appliance material issoft and flexible it does not exert a resilient force that is strongenough to significantly develop the bone structure of the dental arch ofthe user. In addition such an appliance does not make a significantcontribution to alignment of the dentition on the associated arch. Theprimary orthodontic influence conferred by the appliance is to train thepatient to adopt improved myofunctional habits. These improvedmyofunctional habits in turn encourage the patient's dental arch todevelop in a way that leads to better dental occlusion over a period oftime. The development of the arch form in turn provides an environmentin which alignment of the dentition can be sought using otherorthodontic contrivances and techniques.

It would be advantageous if an orthodontic appliance could be devisedthat directed a force onto the dental arch of a patient that was capableof developing the arch form of a user. It would further be advantageousif the orthodontic appliance was capable of achieving this archdevelopment within a reasonable treatment time.

It would be further advantageous if an orthodontic appliance could bedevised that was able to positively influence dental alignment of apatient's teeth along the dental arch as well as to develop the archform.

It would be further advantageous if such an orthodontic appliance wasremovable so that it could be inserted into a patient's mouth, and alsobe removed from the patient's mouth during the course of treatment.

It would be advantageous if an orthodontic appliance could be devisedthat could be manufactured in a number of sizes in a moulding operationand these sizes could then be fitted to a significant cross-section ofthe population. This would create the potential to manufacture theappliance on a commercial scale.

SUMMARY OF THE INVENTION

According to one aspect of the invention there is provided anorthodontic appliance for promoting development of a dental arch form ina patient who has an underdeveloped dental arch, the applianceincluding:

-   -   an arch-shaped base member that is made of a resiliently        flexible material; and    -   a teeth engaging member that encloses at least part of the base        member and that defines at least one of upper and lower dental        arch receiving channels, the teeth engaging member being made of        a resiliently flexible material that is softer and/or flexible        than the resiliently flexible material of the base member and        that is deformable,        wherein the appliance has a resting form in which the resilient        materials of the base member and the teeth engaging member are        in their resting condition, and wherein the appliance can be        flexed or deformed out of the resting form to fit the        underdeveloped dental arch form into the dental arch receiving        channel, and when deformed the appliance exerts a return force        that is directed to returning it to its resting form which in        use urges the underdeveloped dental arch to expand into a        developed dental arch form.

The appliance may have a resting form in which the dental arch receivingchannel has a shape corresponding to the developed dental arch form thatis sought to be achieved in the patient by using the appliance. Thedental arch receiving channel may have a caternary shape correspondingto an arch form representing a correct dental occlusion when theappliance is in the resting form.

The appliance may have a flexibility that permits the appliance to bemanually flexed or deformed out of the resting form to fit theunderdeveloped dental arch into the dental arch receiving channel.

The appliance may include a front region that merges with two opposingarm regions that project away from either side of the front region, andthe front region of the appliance may be less flexible than the armregions and a flexure may be formed at either side of the front regionwhen the arm regions are deflected towards each other.

The material of the base member and the material of the teeth engagingmember may be selected so that they flex in unison with each other whenthey are deformed out of their resting conditions, and also so that thebase member and the teeth engaging member resist delamination from eachother when they are flexed out of their resting conditions.

The teeth engaging member may include an arch-shaped web that definesupper and lower occlusal bite surfaces, and the teeth engaging membermay have inner and outer flanges that project transversely away from atleast one of the upper and lower surfaces of the web, so that eachdental arch receiving channel is defined between the web and the innerand outer flanges.

The web may have a front region and two free ends, and the web maydecrease in transverse width in a direction from the free ends towardsthe front region so as to correspond with the decrease in width of theocclusal surfaces of a dental arch in a direction from a molar regiontowards an incisor region, so that the inner and outer flanges of theteeth engaging member may bear against the dental arch and archstructures, when the appliance is fitted.

The inner and outer flanges may project away from both the upper andlower surfaces of the web defining both upper and lower dental archreceiving channels within which respectively the upper and lower dentalarches of a patient can be received.

The teeth engaging member may substantially fully enclose the basemember. In particular the teeth engaging member may fully encase theentire base member outer surface.

The teeth engaging member may be made from a resiliently elasticmaterial and the resilient elastic material of the teeth engaging membermay be selected so that it is softer than intra-oral soft tissue, so asto form a soft cushioning material for bearing against the dental archand dental structures of a patient.

The teeth engaging member may be made of a polymeric material that issilicone rubber, e.g. a medical grade silicone. The silicone materialcushions the appliance against the dental arch and associated dentalstructures including teeth, gums and other intra-oral tissues of a user.Instead the polymeric material of the teeth engaging member may be madeof a polyvinyl chloride (PVC).

The base member may be in the form of a generally arch shaped open framestructure and may define a front region and two arm regions eachextending to a free end.

The open frame structure may include a curved outer frame member and acurved inner frame member that are spaced apart from each other, and aplurality of spaced apart transverse frame members extending between theouter and inner frame members.

The outer frame member may be generally arch shaped and the inner framemember may be generally arch shaped so that the transverse spacingbetween the inner and outer frame members decreases from their free endsin a direction towards the front region of the appliance, so that anoutline shape of the base member corresponds substantially with that ofthe web when viewed in plan view.

The base member may include a first pair of transverse frame membersincluding one transverse frame member towards one side edge of the frontregion of the appliance and a further transverse frame member towardsthe other side edge of the front region, the left and right transverseframe members being positioned so that they align respectively with theleft and right outer incisors of a patient when the appliance is fitted.

The one and further transverse frame members of the first pair may havea width of 1 to 4 mm, e.g. 2 to 3 mm.

The base member may include a front transverse frame member intermediatethe first pair of transverse frame members.

The front transverse frame member may have a width of 5 to 15 mm (whenmeasured extending from one side edge to the other. For example thefront transverse frame member may have a width of 8 to 12 mm.

The front transverse frame member may be positioned substantiallycentrally with respect to the base member. The front transverse framemember may have a centre point midway along its length that is alignedwith a midline of the base member. The front transverse frame member mayextend across at least part of the two central incisors of a patientwhen the appliance is fitted to a patient.

The base member may further include a second pair of transverse framemembers towards the free ends of the base members. The second pair oftransverse frame members may comprise a left rear transverse framemember towards one free end and a right rear transverse frame membertowards the other free end. In one form the left and right reartransverse frame members may form the free ends of the base member.

Each of the left and right rear transverse frame members may have awidth of 2-10 mm, e.g. about 5 mm.

The base member may further include a third pair of transverse framemembers positioned intermediate the first and second pairs of transverseframe members.

The third pair of transverse frame members may comprise a lefttransverse frame member positioned intermediate said transverse framemember of the first pair and the left rear transverse frame member, anda right transverse frame member positioned intermediate said righttransverse frame member of the first pair and the right rear transverseframe member. The third pair of intermediate transverse frame membersmay be positioned adjacent to the first premolars on the dental archwhen the appliance is fitted to the patient, which are the fourth teethon the arch located in the first and second quadrants.

The third pair of intermediate transverse frame members may bepositioned closer to the left and right rear transverse frame membersthan said left and right transverse frame members of the first pair onthe front region of the base member.

Each pair of intermediate transverse frame members may be symmetricallyarranged on each side of a midline of the base member, e.g. thearrangement of transverse frame members on the base member may bebilaterally symmetrical.

The base member may further include a teeth row repositioning formationprojecting away from the curved outer frame member. The teeth rowrepositioning formation may comprise an outer flange that projects upabove the curved outer frame member.

The outer flange may include a continuous wall on the central frontregion of the base member that extends across the upper incisor teeth ofa patient in use. The central front region may extend up to a height of2 to 10 mm above the transverse frame members, e.g. an upper surface ofthe adjacent or proximate transverse frame members.

The continuous wall may also extend along the left and right arm regionsof the base member that are aligned with some of the molars of a userwhen the appliance is fitted to a patient. The left and right flange armregions may extend up to a height of 2 to 6 mm above the transverseframe members, e.g. an upper surface of the adjacent or proximatetransverse frame members.

The continuous wall may extend in a substantially uninterrupted fashionalong the length of the base member and the height of the continuouswall may vary along the length of the wall.

The outer flange may be formed integrally with the open frame structure,e.g. in an injection moulding operation.

The base member may further include a further teeth row repositioningformation projecting away from the curved inner frame member.

The further teeth row repositioning formation may comprise an innerflange projecting up from the curved inner frame member above the heightof the transverse frame members.

The inner flange on the curved inner frame member may extend a distanceof about 1-3 mm, e.g. about 2 mm up from the transverse frame members,e.g. on the upper surface of the adjacent or proximate transverse framemembers.

The inner flange may project up above the transverse frame members alongat least the front region of the curved inner frame member. The innerflange may project up from the transverse frame members along the fulllength of the curved inner frame member. Further the inner flange mayhave substantially the same height along its full length.

The inner flange may also be formed integrally with the open framestructure, e.g. in an injection moulding operation.

In one form of the invention neither the outer flange on the curvedouter frame member nor the inner flange on the curved inner frame memberextends or depends downwardly below the plane of the open frame to anyappreciable extent.

However it needs to be appreciated that an appliance with one or moredownwardly depending flanges is contemplated to be within the scope ofthe invention. Applicant has found that with the base member materialsthat he has used, a satisfactory stiffness and strength can be obtainedwith outer and inner flanges that project up from the open frame but notdown from the open frame. However if greater rigidity is required to beconferred by the base member for the appliance to perform itsorthodontic function, then the inner and/or outer flanges could dependdownwardly from the open frame as well as projecting upwardly.

In a further alternative the inner and outer flanges described abovecould also be provided projecting down from the plane of the open frameor the transverse frame members instead of projecting up from thetransverse frame members.

The resiliently flexible material of the base member may be a polymericmaterial that is a polyamide material, for example nylon, or an additionpolymer, for example polyethylene or polypropylene, or a condensationpolymer, for example polyurethane, or a polycarbonate, or athermoplastic elastomer, for example santoprene.

In one example form of the invention the base member may be made ofnylon and the teeth engaging member may be made of silicon rubber.

The teeth engaging member may include at least one pair of adjacentteeth positioning formations for bearing against and positioningspecific teeth within the dentition of the associated arch.

Each pair of adjacent teeth positioning formations may be aligned witheach other along the length of the teeth engaging member and may belocated on respectively the inner and outer flanges of the teethengaging member facing into the associated arch receiving channel, beingeither the upper arch receiving channel or the lower arch receivingchannel.

Each adjacent teeth positioning formation may comprise a wedge shapedprotrusion having a wedge point facing into the channel away from theinner or outer flange on which it is located. Further adjacent teethpositioning formation of each pair may be integrally formed with theflange on which it is located, e.g. by being moulded integrally with theremainder of the teeth engaging member.

The teeth engaging member may include a first pair of said adjacentteeth positioning formations that are arranged on the midline of theappliance for positioning between the two inner incisors when mounted ona patient.

The teeth engaging member may include a second and third pair ofadjacent teeth positioning formations that are arranged to be positionedbetween the inner and outer incisors on the left side, and between theinner and outer incisors on the right side.

The teeth engaging member may include fourth and fifth pairs of adjacentteeth positioning formations that are arranged to be positioned betweenthe outermost incisor and the canine on the left side, and the outermostincisor and the canine on the right side of the arch of a patient.

The teeth engaging member may include sixth and seventh pairs ofadjacent teeth positioning formations that are arranged to be positionedbetween the canine and the first pre-molar on the left side, and thecanine and the first pre-molar on the right side of the arch of apatient. The teeth engaging member may include yet further pairs ofadjacent teeth positioning formations for positioning further teeth onthe arch of a user.

In those forms of the invention where the teeth engaging member definesboth upper and lower channels for receiving the upper and lower dentalarches and associated dental structures of a patient, the teeth engagingmember may have pairs of adjacent teeth positioning formations in bothsaid upper and lower channels for positioning specific teeth on both theupper and lower arch of the patient.

The orthodontic appliance may also include a tongue tab for encouraginga patient to correctly position their tongue. The tongue tab may beformed on the inner flange of the teeth engaging member and may bepositioned above the web.

The teeth engaging member may include at least one cutaway or recessabove the web on the inner flange of the teeth engaging member.Conveniently the inner flange may define two cutaways above the web onthe inner flange, namely one on either side of the tongue tab.

The teeth engaging member may include at least one further cutaway orrecess below the web on the inner flange of the teeth engaging member.The further cutaway may be defined on the midline of the appliance.

The one and further cutaways enable the teeth engaging member providespace when the left and arm regions of the appliance are moved towardseach other when the appliance is manually flexed out of its restingform.

The teeth engaging member may include a cut away on the outer flangeabove the web, and another cutaway on the outer flange below the web.These cutaways are formed in the outer flange so that an underlyingregion of the soft gum on the associated dental arch of a patient doesnot make contact with the teeth engaging member when the appliance ismounted on the patient in use.

The web of the teeth engaging member appliance may be formed of varyingthickness along its length. In particular the thickness of the web mayincrease progressively in a direction rearward from the central frontregion of the appliance towards the free ends thereof. The thickness ofthe web may increase up to a point of maximum thickness on each armregion that is short of the free ends of the web. Thereafter thethickness of the teeth engaging member may progressively decrease fromthe point of maximum thickness to the free ends of the web.

The thickening of the teeth engaging member may resemble an invertedaerofoil, e.g. with a curved lower surface and a substantially planarupper surface, when viewed in cross section. By shaping the web regionin this way, the teeth engaging member supports the dentition on theupper and lower arches when the upper and lower jaws are broughttogether.

This encourages relaxation of the muscles, particularly where the userhas a malocclusion and there is a space between the occlusal surfaces ofthe dentition on the upper and lower arches. It also supports thetemporomandibular joint (TMJ joint).

Applicant envisages that the orthodontic appliance will be made inseveral sizes and a suitable size of appliance will be selected for apatient based on the size of their dental arches and associated dentalstructures. Applicant envisages that the appliance will be manufacturedin three or more different arch sizes to accommodate relatively largerarch sizes in patients and relatively smaller arch sizes. Each arch sizewill be manufactured with six or more variations in the arrangements ofthe adjacent teeth positioning formations. The different arrangements ofthe adjacent teeth positioning formations are intended to cater fordifferent teeth sizes and different individual teeth positions indifferent patients.

According to another aspect of this invention there is provided anorthodontic appliance for promoting development of a dental arch form ina patient who has an underdeveloped arch form, the appliance including:

a base member that is made of a resiliently flexible material having ashape that corresponds generally to a dental arch form, and a teethengaging member that encloses at least part of the base member and thatdefines at least one of upper and lower dental arch receiving channels,the teeth engaging member being made of a resiliently flexible materialthat is more flexible than the resiliently flexible material of the basemember and that can be deformed,wherein the appliance comprises a front region and left and right armregions on either side of the front region, and the front region isformed with a greater stiffness than the left and right arm regions, andthe appliance has a resting form in which the resilient materials of thebase member and the teeth engaging member are in their restingcondition, and when the appliance is deformed out of the resting form tofit the underdeveloped dental arch form into the dental arch receivingchannel, the greater stiffness of the front region enables it to exert agreater return force against an anterior region of the dental arch formthan the arm regions bearing against other regions of the dental archform.

The base member may be in the form of an open frame structure comprisinga curved outer frame member and a curved inner frame member, and thefront region of the appliance may be formed with a greater stiffnessthat the left and right arm regions thereof by having at least onetransverse frame member extending between the inner and outerlongitudinal frame members of the base member in said front region.

The at least one transverse frame member extending between the curvedinner and the curved outer frame members in the front region, mayinclude a first pair of transverse frame members including onetransverse frame member towards one side edge of the front region and afurther transverse frame member towards the other side edge of the frontregion.

The transverse frame members of the first pair may be positioned so thatthey align with respectively the left and right outer incisors of apatient. The first pair of transverse frame members may each have awidth of 1-4 mm, e.g. 2-3 mm.

The base member may include a further transverse frame member extendingbetween the curved inner and outer frame members in the front region ofthe appliance, to further stiffen the front region of the appliance, thefurther transverse frame member being positioned between said twotransverse frame members making up the first pair.

The further transverse frame member in the front region of the appliancemay have a width of 5 to 15 mm, e.g. 8 to 12 mm.

The transverse frame arrangement may further include a second pair oftransverse frame members comprising a left rear transverse frame membertowards the rear of the left arm region, and a right rear transverseframe member towards the rear of the right arm region thereof.

The transverse frame arrangement may further include a third pair oftransverse frame members positioned intermediate the first and secondtransverse frame members.

This invention also extends to a method of treating a patient toencourage development of an underdeveloped arch form in patient, themethod comprising the steps of fitting an appliance as described in thefirst or second aspects of the invention above to a patient, and havingthe patient to wear the appliance on a regular basis.

The method may include encouraging development of the upper arch of apatient by expanding the upper arch form to treat a Class 2malocclusion.

The method may include aligning the dentition on the underdevelopeddental arch of the patient that is being encouraged to develop.

Having the patient wear the appliance may include having the patientwear the appliance for at least 12 hours in each 24 hour day. Preferablythe patient wears the appliance at least 2 hours during the day time andduring the night while the patient is sleeping.

DETAILED DESCRIPTION OF THE INVENTION

An orthodontic appliance in accordance with this invention may manifestitself in a variety of forms. It will be convenient to hereinafterprovide a detailed description of at least one embodiment of theinvention with reference to the accompanying drawings. The purpose ofproviding this detailed description is to instruct persons having aninterest in the subject matter of the invention how to put the inventioninto practice. It is to be clearly understood however that the specificnature of this detailed description does not supersede the generality ofthe preceding statements. In the drawings:

FIG. 1 is an upper three dimensional view of an orthodontic appliancethat is an orthodontic appliance in accordance with one embodiment ofthe invention, viewed from the front;

FIG. 2 is an upper rear three dimensional view of the appliance of FIG.1, viewed from the rear;

FIG. 3 is a front view of the appliance of FIG. 1;

FIG. 4 is a rear view of the appliance of FIG. 1;

FIG. 5 is a top plan view of the appliance of FIG. 1;

FIG. 6 is a bottom plan view of the appliance of FIG. 1;

FIG. 7 is a side view of the appliance of FIG. 1 from one side;

FIG. 8 is a side view of the appliance of FIG. 1 from the other side;

FIG. 9 is an upper three dimensional view of part of the appliance ofFIG. 1 with part of a teeth engaging member thereof removed to expose anunderlying base member;

FIG. 10 is an upper three dimensional view of the base member of theappliance of FIG. 9 viewed from the front;

FIG. 11 is an upper three dimensional view of the base member of FIG. 10when viewed from the rear;

FIG. 12 is a top plan view of the base member of FIG. 10;

FIG. 13 is a three dimensional view of the appliance of FIG. 1 in itsresting or original condition prior to use;

FIG. 14 is a schematic three dimensional view of the appliance of FIG.13 showing how left and right arm regions can be moved towards eachother by hand pressure being applied by a patient or a dentalpractitioner;

FIG. 15 is a schematic three dimensional view of the appliance of FIG.13 showing a dental practitioner fitting the appliance to a patienthaving an underdeveloped arch with the dentist squeezing the left andright arm regions towards each other to fit the appliance over theunderdeveloped dental arch of the patient;

FIG. 16 is a schematic top plan view of the appliance of FIG. 13 in aresting state positioned next to a dental arch of a patient having anunderdeveloped arch that is typical of a class 2 malocclusion;

FIG. 17 is a schematic sectional side view of the appliance fitted tothe upper arch of a patient along a dental midline;

FIG. 18 shows the arch shown in FIG. 16 after the orthodontic treatmentof the patient has progressed to the point where the patient's arch hasundergone some development;

FIG. 19 shows two schematic profiles of a patient prior to treatmentillustrating the effect of incorrect swallowing and mouth breathing onthe profile of the patient, and a third schematic profile of a patientafter treatment showing the correct positioning of the arches and lips;and

FIG. 20 is a schematic drawing showing a plan view of the appliance inits resting from and also showing the appliance in a deformed conditionwhen it is fitted to an underdeveloped arch of a patient.

In FIGS. 1 to 9 a reference numeral 1 refers generally to an appliancethat is an orthodontic appliance in accordance with the invention forpromoting development of a dental arch form in a patient who has anunderdeveloped arch.

The appliance 1 comprises broadly a base member 2 having a shape thatcorresponds generally to a dental arch form representing correct dentalocclusion, i.e. a correct dental bite, and that is made of a resilientlyflexible material, and a teeth engaging member 5 that encloses at leastpart of the base member 2 and defines upper and lower dental archreceiving channels. The teeth engaging member 5 is made of a resilientlyflexible material that is deformable and is softer than the resilientlyflexible material of the base member 2.

The appliance 1 has a resting form in which the resilient materials ofthe base member 2 and the teeth engaging member 5 are in their restingcondition, and the appliance 1 can be flexed or deformed out of itsresting form to fit the underdeveloped dental arch form into the dentalarch receiving channel. The appliance 1 when deformed in this way exertsa return force that is directed to returning it to its resting formwhich drives expansion of the underdeveloped arch to a developed archform.

The teeth engagement member 5 is made of silicone rubber and occupies asubstantially greater volume than the base member 2 and forms the bodyand shape of the appliance 1. It also defines the contacting surfacesthat make contact with and engage the arch and associated dentalstructures such as the dentition and other tissues of a patient.

The base member 2 is shown in hidden detail lines in FIGS. 1 to 9 andwill now be described in more detail with reference to FIGS. 10 to 12 inwhich it is shown separate from the teeth engaging member 5.

The base member 2 comprises a front region or central frontal portionthat is indicated generally by numeral 17. It also includes a left armregion 18 extending away from a left side edge of the front region 17,and a right arm region 19 that extends away from a right side edge ofthe front region 17. In this specification the terms left and rightshall be considered from the point of view of the side of a patient'sbody that the feature is located on, when the appliance 1 is mounted ona dental arch of the patient. Thus the left arm region 18 will extendalong the left side of a patient's arch and the right arm region 19 willextend along the right side of the patient's arch. The front region andthe left and right arm regions of the base member correspond broadly toa front region and left and right arm regions of the teeth engagingmember and also the appliance 1 as a whole.

The base member 2 is in the form of an open frame structure 7 extendingin an occlusal plane comprising a curved outer longitudinal frame member10 and a curved inner longitudinal frame member 12. The inner framemember 12 broadly follows the curve on the outer longitudinal framemember 10 but is spaced inward of the outer longitudinal frame member12.

The open frame structure 7 includes a transverse frame memberarrangement indicated generally by numeral 15 comprising a plurality oftransverse frame members interconnecting the outer and innerlongitudinal frame members 10, 12 to form the structure.

The transverse frame member arrangement 15 is designed to stiffen thefront region 17 of the base member 2 so that it requires a greater forceto resiliently flex the front region 17 than the left ands right armregions 18, 19 of the base member 2. The front region 17 also exerts acorrespondingly greater return force when it is flexed out of itsresting position than when the left and right arm regions 18, 19 of thebase member 2 are flexed out of their resting position.

The result is that when the front region 17 of the appliance 1 isdeformed to fit the appliance to dental arch having a narrowed anteriorregion with protruding incisors, the front region 17 of the base member2 and also the appliance 1 as a whole exerts a correspondingly greaterreturn force on the anterior region of the arch than the force appliedto other regions of the arch.

The transverse frame arrangement 15 includes a first pair of transverseframe members 26 including one transverse frame member towards one sideedge of the front region 17 and a further transverse frame membertowards the other side edge of the front region 17. The left and righttransverse frame members 26 of the first pair are aligned withrespectively the left and right outer incisors of a patient (i.e. thesecond teeth in the first and second quadrants) when the appliance 1 isfitted thereto as is shown in the drawings. The first pair ofintermediate transverse frame members 26 have a width of 1-4 mm, e.g.about 2 mm.

The transverse frame member arrangement 15 also includes a fronttransverse frame member 27 extending between the inner and the outerlongitudinal frame members 12, 10 in the front region 17 of the basemember 2. The front transverse frame member 27 is positionedsubstantially centrally with respect to the base member 2 and extendsacross part of the two central incisors of a patient. The fronttransverse frame member 27 has a centre point midway along its lengththat is aligned with a midline of the appliance as a whole.

The front transverse frame member 27 has a width of about 8 to 12 mmmeasured from one side edge thereof to the other side edge thereof andis considerably wider than the first pair of transverse frame members 26of the transverse frame arrangement 15. The additional width serves toconfer additional strength and rigidity in the front region 17 of thebase member 2.

The first pair of transverse frame members 26 together with the fronttransverse frame member 27 together stiffen and rigidify the open framestructure 7 of the base member 2 in the front region 17. This helps thebase member 2 to preserve a developed arch form, e.g. expanded archform, in the anterior region of the appliance 1 when the appliance 1 isdeformed causing the arm regions 18, 19 to move towards or away fromeach other.

The transverse frame arrangement 15 further includes a second pair oftransverse frame members 29 comprising a left rear transverse framemember located at the rear end of the left arm region 18, and a rightrear transverse frame member at the rear end of the right arm region 19.Each of the left and right rear transverse frame members 29 has a widthof 3 to 6 mm.

The transverse frame arrangement 15 further includes a third pair oftransverse frame members 31 comprising a left transverse frame memberpositioned intermediate the left member 26 of the first pair and theleft rear member 29, and a right transverse frame member positionedintermediate the right member 26 of the first pair and the right rearmember 29. The third pair of intermediate transverse frame members 31 istypically of similar thickness to the first pair of intermediatetransverse frame members 26. Each pair of transverse frame members 26,29, and 31 is arranged in a bilaterally symmetrical fashion about themidline of the appliance as is shown in the drawings.

The third pair of intermediate transverse frame members 31 is positionedadjacent to the first premolars on the dental arch when the appliance isfitted to a patient (e.g. the fourth teeth in the first and secondquadrants when viewed in plan view). The third pair of intermediatetransverse frame members 31 is thus positioned quite a bit closer to therear frame members 29 than the first pair of frame members 26 on thefront region 17 of the base member 2. This predisposes the section ofthe base member 2 intermediate the frame members 26 and the framemembers 31 to undergo flexing when the appliance 1 is deformed in use.

The base member 2 also includes a teeth row repositioning formation thatis an outer flange 25 in the form of a continuous outer wall extendingthe length of the outer frame member 10 that projects up from the outerframe member 10 and defines an upper edge. The outer flange 25 projectsup above the plane defined by the outer and inner members 10 and 12 andthe transverse frame members of the transverse frame member arrangement15 and contribute to the rigidity and stiffness, and torsional rigidity,of the base member 2.

The outer flange 25 comprises a front flange portion extending acrossthe front region 17 of the base member 2 and left and right flangeportions extending across the left and right arm regions 18, 19 thereof.The upper edge of the front flange portion extends up to a height of 6-8mm above the transverse frame members 15. The upper edges of the leftand right flange portions are not as high as the left and right flangeportions and extend up to a height of 5-7 mm above the transverse framemembers 25. The height is measured from the upper surface of a proximatetransverse frame member 25 to the upper edge of the inner flange 30. Theouter flange 25 forms a continuous wall along the length of the arch andpromotes alignment of the dentition of the upper arch of a patient in arow or line along the arch.

The outer flange 25 also defines canine gaps shown by numeral 28 on eachside thereof. Each canine gap 28 is formed by having the upper edge ofthe outer flange 25 descending to a low point intermediate the centralfront portion 17 and the left and right portions and then ascendingupwards again.

The canine gaps 28 on the upper edge of the outer flange 25 are locatedin the position where the eye teeth or canine teeth of a patient wouldbe located. The canine gaps 28 expose more of the canine teeth when theappliance 1 is being worn so that the outer flange 25 does not need tofit around the canine teeth. Applicant has observed that the canineteeth of a patient are sometimes positioned laterally outward of theother teeth prior to treatment, and the canine gaps 28 permit the canineteeth to project through the gaps and thereby fit the appliance to apatient even where there is considerable misalignment.

In the illustrated embodiment the base member 2 also includes a curvedinner flange 30 in the form of a continuous wall projecting up from theinner frame member 12. The inner flange 30 defines an upper edgeprojecting up to a height that is 1-3 mm, e.g. about 2 mm, above thetransverse frame members and is lower and less prominent than the outerflange 25. The height is measured from the upper surface of a proximatetransverse frame member 25 to the upper edge of the inner flange 30. Theinner flange 30 can also contribute to the rigidity and stiffness thebase member 2. The curved inner flange 30 can also assist with aligningteeth in a row along the arch.

The base member 2 in the drawings does not have a flange depending orextending down below either the outer frame member 10 or the inner framemember 12 of the base member 2 to any appreciable extent. Applicant hasfound that having an outer flange 25 that projects up from the openframe structure 7 but not down there from provides the base member 2with the necessary level of stiffness. However a flange that alsoprojects downwardly away from the curved outer frame member 10 wouldfurther increase the strength of the base member and falls within thescope of this invention.

In another embodiment of the invention that has not been illustrated theorthodontic appliance and specifically the base member thereof does nothave an inner flange 30.

The base member 2 defines a pair of openings 38, 39 in its central frontregion 17 that relate to the moulding process that is used tomanufacture the appliance 1. The openings 38, 39 are formed in both theinner and outer curved frame members 12, 10 of the base member 2 on leftand right sides of the front region 17 of the base member 2, and areintegrally formed in the base member 2. The openings 38, 39 are alignedwith corresponding openings in the teeth engaging member 5 as will bedescribed in more detail below.

The teeth engaging member 5 that surrounds and encases the base member 2will now be described in detail.

Broadly the member 5 comprises a central web 40 and an inner flange 44and an outer flange 45 (or inner and outer walls) 44, 45 thatrespectively upwardly and downwardly away from the web 40. These flanges44, 45 together with the web 40 form an upper channel 46 and a lowerchannel 47 within which the upper and lower dental arches and associateddentition of a patient are received. The web 40 forms occlusal bitesurfaces that bear against the bite surfaces of the dentition of theupper and lower dental arches.

The teeth engaging member 5 comprises a front region 51, and left andright arm regions 48 and 49 corresponding to the front region 17 andleft and right arm regions 18 and 19 of the base member 2. The frontregion 51 of the teeth engaging member 5 is mounted over and encases thefront region 17 of the base member 2 and has the same extent as thefront region 17 of the base member 2. That is the side edges of thefront regions 17, 51 of respectively the base member 2 and the teethengaging member 5 broadly coincide.

The front region of the appliance is basically the same as the frontregion of the teeth engaging member 5 and the left and right arm regionsof the appliance are basically the same as the left and right armregions of the teeth engaging member 5. The left and right arm regions48, 49 have a greater longitudinal extent than the left and right armregions of the base member 2 as shown in the drawings and particularlyin FIGS. 2, 5 and 6. That is the rear edges of the teeth engaging member5 are spaced rearward of the rear edges of the base member 2.

The teeth engaging member 5 fills in the space between the inner andouter longitudinal frame members 12, 10 and the transverse frame members26, 27, 29 and 31 also forms a layer having some thickness above andbelow the inner and outer frame members 12, 10.

The left and right arm regions 48, 49 have a greater longitudinal extentthan the left and right arm regions of the base member 2 as shown in thedrawings and particularly in FIGS. 2, 5 and 6. That is the rear edges ofthe teeth engaging member 5 are spaced rearward of the rear edges of thebase member 2.

The appliance 1 also includes an adjacent teeth positioning arrangementshown generally by reference numeral 50 on the inner and outer flanges44, 45 of the teeth engaging member 5 for assisting in positioningspecific teeth in certain positions along the line of the arch.

Specifically the adjacent teeth positioning arrangement 50 comprises aplurality of pairs of adjacent teeth positioning formations. Each pairof positioning formations comprises a first positioning formation on theouter flange 45 of the member 5 projecting from the channel surfacethereof into the upper dental arch channel, and a second positioningformation on the inner flange 44 of the member 5 projecting from thechannel surface thereof into the upper arch channel. The first andsecond positioning formations in each pair are aligned with each otherin a lengthwise direction along the channel.

Each teeth positioning formation within each pair comprises a protrusionthat extends away from the surface of the flange on which it is locatedto a terminal free end that is spaced away from the channel surface. Thepositioning formations are wedge shaped when the appliance is viewed inplan view tapering inwardly from both sides on the surface of the flangeto a wedge point. The wedge point extends in a line broadly transverseto the plane of the web of the member 5 as is shown in the drawings.That is the terminal free end is broadly vertically extending when theappliance is fitted to a patient and is designed to fit into theinterproximal space between two adjacent teeth on an arch in use. Thefirst and second positioning formations of each pair are integrallyformed with the flange on which they are located when the member ismoulded during its manufacture.

In the illustrated embodiment the adjacent teeth positioning arrangement50 has nine pairs of adjacent teeth positioning formations on the upperchannel for interacting with the upper dental arch structures of apatient.

This arrangement includes a first pair of said adjacent teethpositioning formations that are arranged on the midline of the appliancefor positioning between the two central incisors when mounted on apatient. It also includes a second and third pair of adjacent teethpositioning formations are arranged to be positioned between the centraland outer incisors on the left side, and between the central and outerincisors on the right side. It also includes fourth and fifth pairs ofadjacent teeth positioning formations are arranged to be positionedbetween the outermost incisor and the canine on the left side, and theoutermost incisor and the canine on the right side of the arch of apatient. It also includes sixth and seventh pairs of adjacent teethpositioning formations are arranged to be positioned between the canineand the first pre-molar on the left side, and the canine and the firstpre-molar on the right side of the arch of a patient. It also includeseighth and ninth pairs of adjacent teeth positioning formations arearranged to be positioned between the first pre-molar and the secondmolar on the left side, and the first pre-molar and the second molar onthe right side of the arch of a patient.

In the illustrated form of the invention where the teeth engaging member5 defines both upper and lower channels for receiving the upper andlower dental arches and associated dental structures of a patient, theteeth engaging member 5 includes a similar arrangement of pairs ofadjacent teeth positioning formations on the inner and outer flanges andprojecting into the lower channel for receiving the lower dental archand associated dental arch structures of a patient.

The adjacent teeth positioning formations 50 are for biasing individualteeth into specific teeth positions on the dental arch of the patient.The pairs of adjacent teeth positioning formations are positioned sothat they insert between adjacent teeth on the dental arch when theappliance is mounted on the dental arch. The wedge shape tends to urgeteeth apart from each other and to form a space between adjacent teeth.The pairs of teeth positioning formations urge the adjacent teeth apartfrom each other and thereby form a space between the adjacent teeth. Theadjacent teeth positioning formations are located in the anterior regionof the arch and thus they work to form spaces between adjacent teeth inthe anterior region of the dental arch.

As the teeth on the dental arch are generally in end to end contact whenthe treatment commences, the arch needs to expand to create additionalspace for spaces between the adjacent teeth to be formed. The teethpositioning formations project into the space between adjacent teeth andpush them apart which in turn encourages the arch to expand to providethe extra space. The teeth positioning arrangements thereby also subtlyencourages the arch to expand in addition to the arch developing forceof the deformed appliance fitted to a patient as described above. Theteeth positioning formations also help to position individual teeth inspecific positions along the length of the arch.

In the illustrated example the orthodontic appliance also includes anotch or cut-out 55 in the midline of the upper surface of the outerflange 45. It also includes a smaller midline notch or cut-out 57 in thelower surface of the outer flange 45. The notches 55, 57 form a recessor gap on the appliance midline so that the member 5 does not come intocontact with soft tissue in the area of the dental midline. There is atendon that extends across the dental midline and the appliance 1 can bemore comfortably worn by a patient if the teeth engaging member 5 doesnot come into contact with this tendon. The recesses 55, 57 avoidcontact with this tendon.

The orthodontic appliance 1 also has a tongue tab 60 for positioning thetongue of a patient in an exact central position. The tongue tab isformed in the inner flange 44 of the member 5 upwardly of the web 40.This trains a patient to correctly position their tongue to improvetheir oral habits and particular to avoid tongue thrusting.

The inner flange 44 defines gaps on either side of the tongue tab 60 asshown in FIG. 4. The inner flange also defines a small notch or cutaway57 formed in the lower edge of the inner flange as shown in FIG. 4.These spaces help to facilitate inward and outward adjustment of the armregions 48, 49 of the teeth engaging member 5 of the appliance 1 toenable it to be fitted to an underdeveloped arch.

Further the occlusal surfaces of the web 40 of the teeth engaging member5, e.g. upper and lower faces thereof, taper outwardly from the frontregion 51 of the member 5 in a rear direction to the left and righttrailing arm regions 48, 49. The effect of this is to progressivelythicken the web 40 in a direction from the front to the rear of theteeth engaging member 5. This continues up to a point in the left andright trailing arm regions 48, 49 that is spaced forward of the rearends of the arm regions. Thereafter the upper and lower faces of theengaging member 5 taper inwardly towards each other so as toprogressively thin from said point to the rear of the teeth engagingmember 5. In summary the web 40 can generally be described as having aninverted asymmetric aerofoil shape on each arm region 48, 49 extendingin a direction rearward from the front region 51. The aerofoil isinverted and has a curved surface on its lower side.

This aerofoil shape of the web 40 fills in any space that exists betweenthe upper and lower teeth of a patient as a result of malocclusion andsupports the jaw. This enables the lower jaw to assume its anatomicallycorrect position in relation to the upper jaw. This supports thedentition in cases where the occlusal surfaces of the dentition of theupper and the lower arches are spaced from each other and helps thepatient to relax and not clench their jaw. It also confers othermuscular benefits on the patient.

The teeth engaging member 5 also has passages defined therein in thesame place as the apertures 38, 39 of the base member 2. These passagesare continuous and open at both ends. The openings 38 and 39 defined inthe base member 2 increase the surface area of the teeth engaging member5 in contact with the base member 2. This assists in moulding the teethengaging member 5 onto the base member 2.

During manufacture of the orthodontic appliance the base member 2 isinjection moulded in a first injection moulding step, and the teethengaging member 5 is then moulded around the base member 2 in a secondmoulding step.

The base member 2 is made of a polymeric material having suitablephysical properties of stiffness and resilient flexibility to enable theappliance to perform its orthodontic function. In the illustratedembodiment the base member is made of a polyamide material that isnylon. Nylon is a generic name of any long chain synthetic polymericamide which has recurring amide groups as an integral part of the mainpolymer chain. The polymer is linear and as such is suited to beingformed into a filament although it can also be used to form a threedimensional body. Nylon has been found to have an appropriate level ofrigidity yet the base member as a whole is resiliently flexible and canbe resiliently flexed out of its resting form so that the left and rightarm regions of the base member can be moved towards and away from eachother. It also permits some twisting of the left and right arm regionsrelative to each other.

Further when silicon rubber is used as the material for the teethengaging member it is able to withstand the injection temperature ofsilicone when it is injected onto the base member to form the teethengaging member.

Applicant has obtained Nylon from Shinko Chemical Company based inTaipei, Taiwan. The table below indicates the different grades of Nylon66 supplied by this company.

TENSILE Kg/cm² 800 900 1700 1900 840 1150 STRENGTH ELONGATION % 55 107.1 2 4 4.5 FLEXURAL Kg/cm² 1000 1350 2300 2600 1200 1700 STRENGTHFLEXURAL Kg/cm² 28000 35000 80000 108000 31000 72000 MODULUS IZOD IMPACTKg- 13 8.5 11 9 7.3 7 STRENGTH cm/cm ROCKWELL R- 118 119 120 120 118 119HARDNESS SCALE MELTING ° C. 260 260 255 260 260 260 POINT M. D. T ° C.66 200 238 240 73 248 (18.6 kG/cm2) M. D. T ° C. 230 240 255 255 230 245(4.6 kG/cm2) ASH W1% 13 33 45 — 25 CONTENT MOLD 1.7-1.8 0.3-0.5 0.2-0.40.2-0.3 1.0-1.3 0.3-0.5 SHRINKAGE 1.3-1.4 0.8-1.0 0.7-1.0 0.3-0.50.7-1.0 0.7-1.0 M. F. g/10 min 55 20 13 10 43 20 SP Gr g/cm² 1.1 1.21.35 1.46 1.16 1.38

A grade of Nylon can be used having a tensile strength 800-1000, e.g.about 900, a flexural Strength 1000-1500, e.g. about 1350, and aROCKWELL Hardness of 90-150, e.g. about 119. In particular Applicant hasused a grade of nylon known as Nylon 66 6212GA for the manufacture ofappliances in accordance with this invention.

A suitable nylon material can also be obtained from other chemicalsuppliers such as E I. Du Pont Nemours Chemical Company (Du Pont) basedin Delaware in the USA and other suppliers.

In the illustrated embodiment the teeth engaging member is formed of asilicone rubber. A medical grade silicon rubber that is a basiccommodity that can be obtained from a number of suppliers such Du PontChemical Company based in Delaware in the USA. Applicant has sourced asuitable silicone rubber from a Japanese chemical company by the name ofShin-Etsu Chemical Co Ltd based at 6-1, 2 Chome, Ohtemachi, Chiyodaku,Tokyo, Japan. The material specification data sheet provided byShin-Etsu for this material is provided below.

Material Specification Data Sheet

Transparent High Strength SHIN-ETSU ® TWO-COMPONENT KE- KE- KE- SILICONERUBBER COMPOUND 1950-50 1950-60 1950-70 Typical Properties Units (A-B)(A-B) (A-B) Viscosity in mPa · s 680 730 750 (P) Brookfield-type (6800)(7300) (7500) rotational viscometer Specific Gravity at g/cm³ 1.13 1.141.15 25° C. (77° F.) Mixing Ratio A:B 1:1 1:1 1:1 Hardness JIS-A 50 5868 Tensile Strength JIS-6301 Mpa 9.3 7.8 7.8 Elongation at breakJIS-6301 % 55 380 350 Tear Strength JIS-6301 kN/m 44.1 43.1 49Compression set 22 h/150° C. (%) 28 22 50 Linear Shrinkage JIS-6301 (%)2 1.9 2.1 Volume Resistivity Ω-m 10T 10T 10T Comments

The silicone rubber used to make the orthodontic appliance can have thefollowing properties:

-   Hardness of 50-68 according to JIS-A;-   Tensile strength of 7.8 to 9.3 Mpa according to JIS-6301;-   Elongation at break 55 to 350% according to JIS-6301;-   Tear strength of 43.1 to 49 KN/m according to JIS-6301;

Applicant has used the hardest grade of silicon extensively, namelyKE-1950-70 supplied by Shin-Etsu.

Another supplier of silicone rubber is the Bayer Chemical Company basedin Leverkusen, Germany. Bayer supplies a liquid silicone rubber LSR 2050that is non toxic and suitable as a medical grade material. It is a twocomponent rubber with each component packed in a separate container.These two components are pumped into a static mixer and mixed thoroughlyand then injected into the injection mould die.

In the actual moulding of the orthodontic appliance 1 the base member 2and the teeth engaging member 5 can be moulded in a co-injectionmoulding process. The base member 2 is moulded in a first step by aninjection moulding process and then the teeth engaging member 5 ismoulded onto the base member 2 in a second moulding step. The basemember 2 does not have to be removed from the mould for the teethengaging member 5 to be moulded onto it. The mould comprises two mouldparts, a first mould part for the base member 2 and a second mould partfor the teeth engaging member 5 and the teeth engaging member 5 ismoulded directly onto the base member 2 without it being removed fromthe mould.

During the moulding operation the first mould part is mounted in anoperative moulding position in a moulding zone in a first moulding step.Thereafter molten nylon is injected into the first mould part in a firstmoulding step to form the base member 2. Thereafter the first mouldingpart is withdrawn from the moulding zone and the second moulding part ismoved into its operative position in the moulding zone. Thereaftermolten silicon rubber is injected into the second mould part in a secondmoulding step to mould the teeth engaging member onto the alreadymoulded base member that is received within the second moulding part.The second moulding part is then withdrawn to reveal the newly mouldedappliance with the base member encased within the teeth engaging member.Generally the formed orthodontic appliance 1 can be removed from the dieonce the moulded silicon rubber material has had an opportunity to coolsufficiently for it to be handled.

The cycle times for each of the moulding steps is typically about 15seconds. The cycle time for the silicone rubber moulding is longer thanthat for the nylon base member. Generally the moulded pieces are allowedto cool passively. However the silicone rubber which is moulded at ahigh temperature can be actively cooled once it has been moulded.Generally the formed orthodontic appliance 1 can be removed from the dieonce the moulded silicon rubber material has had an opportunity to coolsufficiently for it to be handled.

The molten silicone is introduced to the die at a very high temperatureand therefore the moulded base member has to be able to withstand thistemperature. Nylon is capable of withstanding the injection temperatureof silicone and this property as well as its other physical propertiesthat make it suitable for use in the base member of the appliance.

In another form of the invention the appliance can be moulded in twoseparate dies with the base member being moulded in a first die then thebase member can be removed and be placed in a second die where the teethengaging member is moulded onto the base member 1.

In use the orthodontic appliance 1 described above will typically beinitially fitted by an orthodontist or a dentist.

A first step in fitting an appliance 1 is to choose an appropriatelysized appliance from the different sizes of appliances. The range ofappliances 1 envisaged by the Applicant will have at least threedifferent sizes of base member defining the basic arch form. Each ofthese base member sizes will then have at least four different sizes ofteeth engaging member some of which have an adjacent teeth positioningarrangement thereon and others which do not have a teeth positioningarrangement. Generally an orthodontist will choose a size of applianceafter inspecting and measuring the dental arch and associated dentalarch structures of the patient using a suitable measuring device that issupplied to the dental practitioner.

This procedure of fitting the appliance to a dental arch of a patient isshown schematically in FIGS. 13 to 15. Where the patient has an underdeveloped arch structure such as that found in a class 2 malocclusion,the dentist will manually flex the left and right arm regions 48, 49 ofthe teeth engaging member 5 and base member 2 towards each other. Thismovement of the arm regions enables the appliance 1 to be narrowed tothe point where it can be fitted over the upper dental arch with a tightfit and a tight grip which is shown schematically in FIG. 17. Thesilicone rubber is also resilient and can be deformed together with thebase member when the appliance is deformed to fit it to anunderdeveloped arch.

The soft silicone rubber of the teeth engaging member 5 is in contactwith and bears against the dental structures including the gums andteeth of the patient. The silicon rubber cushions the underlying forcebeing applied by the deformed base member so that the appliance isreasonably comfortable to wear despite the return force that is beingapplied to the arch to encourage expansion of the arch.

The inner and outer flanges 44 and 45, and the occlusal surfaces of theweb 40 of the teeth engaging member 5, bear against the upper and lowerdental arches and the associated arch structures. The teeth engagingmember 5 transmits the force generated by the appliance 1 being flexedout of its resting form through to the dental arch and associated dentalstructures of the patient.

The underlying rigidity of the base member 2 in particular generates aforce that bears against the dental arch and associated dentalstructures of the patient that have a physiological influence on thebone development of the dental arch form that drives expansion of thearch form. The dental arch form is encouraged to develop into an archform corresponding to the resting form of the appliance 1 whichcorresponds to a developed arch form that is conducive to correct dentalocclusion. Applicant regards the resilient force that is generated bythe base member when it is deformed out of its original shape and whichis applied through the appliance to the dental arch as being analogousto active spring energy.

FIG. 16 show an appliance in its original shape next to anunderdeveloped dental arch that requires expansion into a more developedarch form. The drawings clearly show how the arch form of the appliance1 is noticeably wider than the dental arch of the patient. Consequentlythe appliance 1 has to undergo significant deformation, and specificallya movement of the arm regions towards each other to fit the appliance 1over the underdeveloped arch form of the patient. The deformation causesthe appliance 1 to exert a buccally directed return force against thedental arch and associated dental structures of the patient.

Over time this force will encourage progressive expansion of the archand it will become progressively develop an arch form that is moresimilar to the resting form of the appliance. FIG. 18 shows the arch ofthe patient of FIG. 15 after it has undergone treatment with the oralappliance and the anterior region of the arch has widened into adeveloped arch form.

The distance X between the inner surface of the left and right canineteeth in FIG. 18 is much greater than that in FIG. 16. Further theradius of curvature of the line of teeth in the anterior portion of thearch in FIG. 18 shown by R is much greater than that in FIG. 18 therebyshowing clearly how the treatment develops the arch and in particularexpands the anterior region of the arch.

In addition to influencing arch development on the patient theorthodontic appliance 1 and particularly the teeth engaging member 5thereof is in contact with the dentition and applies an aligning forceto the dentition on the arch. As the appliance 1 has channels that arearranged in a neat curve, the appliance 1 will influence the dentitionto align along a similar curve. The rigidity of the base member 2, andin particular the continuous outer flange on the base member 2,contributes to alignment of the dentition on the arch by encouragingprotruding and retruding teeth to move to their desired positionreceived within the relevant channel. The teeth are moved into aposition between the inner and outer walls or flanges 44, 45 of theteeth engaging member 5 thereby aligning the teeth with other teeth inthe row. Thus the use of the appliance over a period of time alsoassists with the alignment of teeth in a row along the arch. Theapplication of force to move teeth is standard practice in orthodonticsand the physiological mechanism by which tooth movement is accomplishedis understood by the dental and orthodontic community and will not bedescribed in this specification.

Further the adjacent teeth positioning arrangement 50 on the teethengaging member 5 also encourages individual teeth to adopt a certainposition along the line of the arch.

The orthodontic appliance is a removable appliance that is worn for anumber of hours each day and is not worn by a patient at other times ofthe day. The appliance should be worn for a few hours in the day timewhen this is possible. The appliance should also be worn each night by apatient while they are sleeping. This extent of usage is sufficient tocarry out the treatment effectively. As the appliance has both upper andlower channels that receive both the upper and lower dental arches of apatient, it is not suitable for being worn while the patient is carryingout certain activities. For example a patient could not talk or eatwhile they were wearing the appliance. Over time with proper use of theappliance and good patient compliance, the application of force by thebase member that has been deformed out of its original shape will causethe arch to develop. Once the arch widens crowding of teeth willdiminish and the forces generated by the appliance 1 will encourage theteeth to align with each other along the arch.

FIG. 19 shows a sequence of schematic profiles of a patient showing howtheir profile develops with the progression of treatment with theorthodontic appliance. The first two drawings show the effect ofincorrect swallowing and mouth breathing on the profile of the patient.This is evident in the relative positioning of the upper and lowerarches and the lip profile. The third drawing shows the profile of thepatient after treatment has been completed. The upper and lower archesare correctly positioned relative to each other in the third drawing andthe lips are together.

FIG. 20 is a schematic drawing showing a plan view of the appliance in aresting condition and then also showing how the appliance can bedeformed to fit it to an underdeveloped dental arch of a patient. In theschematic drawing the patient has an underdeveloped upper arch thatneeds to be expanded, particularly in the anterior region thereof. Thefront region of the appliance in particular is flexed and deformed tofit the appliance to the arch. The front region has a greater stiffnessthan the left and right arm regions of the appliance as has beendescribed above. Consequently when deformed, the front region exerts areturn force that is related to the force required to flex it out of itsresting condition and this return force is applied to the underdevelopedarch of a user and encourages it to develop. This force is greater thanthe force applied by the arm regions when they undergo a correspondingamount of deformation. The arrows on the schematic drawing indicateschematically the direction and the strength of the return force that isapplied by the deformed front region of the appliance. The longer arrowsin the front region shown in the drawings show that the return forceapplied by the deformed front region is greater than the return forceapplied by the arm regions when flexed. The strong return force appliedby the front region of the appliance encourages the anterior region ofthe dental arch corresponding to the incisors and the canines todevelop.

In another embodiment of the invention that has not been illustrated inthe drawings, the base member 2 is made out of nylon and the teethengaging member is made of polyvinylchloride (PVC). PVC resin is astaple commodity that is supplied by a number of chemical manufacturersincluding IMPRODEX which is a division of Pacific Dunlop Limited basedat 135 Racecourse Road, Flemington, VIC, Australia. The specificationfor the product used by the Applicant is HYCO 4016-89 PVC compound.Applicant has used a clear extrusion grade PVC compound for theappliance which is supplied by IMPRODEX as their HYCO 4016-89 PVCcompound. The properties of this PVC grade are as follows:

SPECIAL PROPERTIES Shore A Hardness (ASTM 2240) Instantaneous 79 Shore AHardness (ASTM 2240) 10 second delay 71 Specific Gravity 1.22 TensileStrength 17.7 Mpa Elongation at Break 400%

An appliance in which PVC is substituted for silicon is manufactured bya similar two step moulding process to that described above. The basemember is moulded of nylon in a first step and then the teeth engagingmember is moulded of PVC in a second moulding step. An advantage ofusing PVC instead of silicone rubber is that it does not require as highan injection temperature as silicon rubber when it is moulded. Thisreduced injection temperature reduces the mould temperature that themould equipment and also the material of the base member must bedesigned to withstand when the molten PVC is injected into the mould.This opens up the possibility of using materials other than nylon forthe base member. Applicant envisages that addition polymers, e.g. suchas polyethylene, and polypropylene could also be used. Applicant alsoenvisages that condensation polymers such as polyurethane andpolycarbonate and a thermoplastic elastomer such as santoprene couldalso be used because they have a suitable amount of stiffness orrigidity and when they are formed into a base member. The left and rightarm regions thereof would be able to be moved towards and away from eachother. Further Applicant believes that other thermoplastic materialscould also be found to meet these requirements and to be suitable.

In use an orthodontic appliance with a member 5 made of PVC is used inthe same way as the appliance described above with reference to FIG. 1.Further the appliance functions in exactly the same way when fitted tothe dental arch and associated arch structures of the patient.

An advantage of the appliance described above with reference to thedrawings is that it can apply an orthodontic force when it is deformedout of its resting condition that directs it to return to its restingcondition. The force is strong enough to encourage an underdevelopedarch on a patient that is typical of a class 2 malocclusion to developover time with ongoing use of the appliance into a more fully developedarch form that is conducive to a correct dental occlusion. The forcethat is applied to the teeth is comparable to that achieved by otherorthodontic appliances.

The force is due to the underlying resilience of the base member and istransmitted through to the patient's dental arch and associated archstructures by means of a teeth engaging member that is also resilientlyflexible. If the arch form of the patient is narrow, the appliancegenerally and particularly the inner and outer frame members thereof,are resilient and can be deformed to be fitted over the underdevelopedarch. The return force then urges the dental arch and associated archteeth in a direction that would expand the arch form to provide a widerarch in the anterior region of the arch.

Yet further the appliance assists in aligning the dentition on bothdental arches. The appliance has upper and lower dental arch receivingchannels and it applies a teeth repositioning force that promotesalignment of the teeth along a line defined by the arch receivingchannels. The appliance promotes alignment of both protruding andretruding teeth. Further if one or more teeth are rotated, with thedistal edge protruding and the mesial edge being retruded, then theinner and outer flanges of the teeth engaging member defining the archreceiving channels apply a force to the protruding or retruded teeth toencourage rotational realignment to the correct position.

The flange or continuous wall on the outer curved frame member of thebase member together with the teeth engaging member in particularassists with encouraging alignment of teeth along the arch. Further ifone or more teeth are rotated, with the distal edge protruding and themesial edge is retruded, then the inner and outer flanges of the teethengaging member also apply a force to encourage rotational realignmentto the correct position. The adjacent teeth positioning arrangement alsoassists with rotational realignment of individual teeth.

Thus in addition to promoting expansion of the arch form the appliancealso promotes alignment of the dentition of both the upper and lowerdental arches in a row corresponding to the shape of the channels withinwhich the dentition is received. Thus the appliance promotes both archwidening and alignment in a single appliance that is a removableappliance. Applicant believes that this functionality has not previouslybeen obtained in a single orthodontic appliance.

The appliance also has an adjacent teeth positioning arrangement thatcan also assist in encouraging an arch form to expand over and above thearch expansion promoted by the return force of the appliance when it isdeformed. The teeth positioning arrangement can also assist withrotational realignment of individual teeth.

A further advantage of the orthodontic appliance described above is thatthe silicone rubber is a soft material that has a significant ability todeform. It therefore has the ability to deform significantly to fit theappliance to the dental arch structure of a patient having a shape thatis quite different to that of the appliance.

Further the silicone rubber has an ability to cushion the force that isapplied by the appliance to the dental arch and dental structures of apatient. As a result the teeth engaging member does not apply excessivelocal pressure to the teeth and gums, and is comfortable to wear evenwhen the base member has been significantly deformed. This is importantwhen one considers that it is necessary to obtain a certain level ofpatient comfort when wearing the appliance. For example the patient hasto be able to sleep while they are wearing the appliance and also beable to perform other activities when they wear the appliance while theyare awake. Further patient compliance is a crucial factor in achieving asuccessful treatment outcome and wearer comfort is important to achievethis. Further the appliance does not have sharp surfaces that would tendto injure the soft tissues in a patient's mouth.

Another advantage of the appliance described above with reference to thedrawings is that it incorporates certain other features that have beenshown to improve the myofunctional environment in the patient's mouth byimproving on their oral habits. These myofunctional features include atongue tab for correctly positioning the tongue of the patient. Theyalso include features for inhibiting mouth breathing, incorrectswallowing and tongue thrusting. These features also correctly positionthe upper jaw relative to the lower jaw whereby to support the TMJjoint.

A yet further advantage is that the orthodontic appliance can bemanufactured in a commercial scale manufacturing operation in largequantities. In particular the appliance can be injection moulded in atwo step moulding operation in a number of sizes as has been describedabove in the detailed description which enables it to be produced atreasonable cost. The appliance can be manufactured on a large scale andbe supplied to the market at a lower cost than existing orthodontictreatments including braces. This opens up the possibility oforthodontic treatment becoming accessible to a far greater percentage ofthe global population than is currently the case, particularly indeveloping countries.

It will of course be realised that the above has been given only by wayof illustrative example of the invention and that all such modificationsand variations thereto as would be apparent to persons skilled in theart are deemed to fall within the broad scope and ambit of the inventionas herein set forth.

1. An orthodontic appliance for promoting development of a dental archform in a patient who has an underdeveloped dental arch form, theappliance including: an arch-shaped base member that is made of aresiliently flexible material, in the form of a generally arch-shapedopen frame structure defining a front region and two arm regions, eachextending to a free end, the open frame structure including: a curvedouter frame member and a curved inner frame member that are spaced apartfrom each other; a first pair of transverse frame members comprising onetransverse frame member towards one side edge of the front region and anadditional transverse frame member towards the other side edge of thefront region, the one and the additional transverse frame membersaligning respectively with the left and right outer incisors of apatient when the appliance is fitted to the patient; and a fronttransverse frame member intermediate the first pair of transverse framemembers; and a teeth engaging member that encloses at least part of thebase member and that defines at least one of upper and lower dental archreceiving channels, the teeth engaging member being made of aresiliently flexible material that is softer than the resilientlyflexible material of the base member and that is deformable, wherein theappliance has a resting form in which the resilient materials of thebase member and the teeth engaging member are in their restingcondition, and the appliance can be flexed or deformed out of theresting form to fit the underdeveloped dental arch form into the dentalarch receiving channel, and when deformed the appliance exerts a returnforce that is directed to returning it to its resting form which in useurges the underdeveloped dental arch to expand into a developed dentalarch form.
 2. An orthodontic appliance according to claim 1, wherein theappliance has a resting form in which the dental arch receiving channelhas a shape corresponding to the developed dental arch form that issought to be achieved in the patient by applying the appliance.
 3. Anorthodontic appliance according to claim 1, wherein the appliance has aflexibility that permits the appliance to be manually flexed or deformedout of the resting form to fit the underdeveloped dental arch into thedental arch receiving channel.
 4. An orthodontic appliance according toclaim 1, wherein the appliance includes a front region that merges withtwo opposing arm regions that project away from either side of the frontregion, and the front region of the appliance is less flexible than thearm regions, so that a flexure is formed at either side of the frontregion when the arm regions are deflected towards each other.
 5. Anorthodontic appliance according to claim 4, wherein the material of thebase member and the material of the teeth engaging member are selectedso that they flex in unison with each other when they are deformed outof their resting conditions, and also so that the base member and theteeth engaging member resist delamination from each other when they areflexed out of their resting conditions.
 6. An orthodontic applianceaccording to claim 5, wherein the teeth engaging member includes anarch-shaped web that defines upper and lower occlusal bite surfaces, andthe teeth engaging member has inner and outer flanges that projecttransversely away from at least one of the upper and lower surfaces ofthe web, so that the at least one dental arch receiving channel isdefined between the web and the inner and outer flanges.
 7. Anorthodontic appliance according to claim 6, wherein the web has a frontregion and two free ends, and wherein the web decreases in transversewidth from free ends of the web towards the front region so as tocorrespond with the decrease in with of the occlusal surfaces of adental arch from a molar region towards an incisor region, so that theinner and outer flanges of the teeth engaging member bear against thedental arch and arch structures, when the appliance is fitted.
 8. Anorthodontic appliance according to claim 6, wherein the inner and outerflanges project away from both the upper and lower surfaces of the webdefining both upper and lower dental arch receiving channels withinwhich respectively the upper and lower dental arches of a patient can bereceived.
 9. An orthodontic appliance according to claim 4, wherein theteeth engaging member substantially fully encloses the base member. 10.An orthodontic appliance according to claim 4, wherein the teethengaging member is made from a resiliently elastic material, and theresiliently elastic material is selected so that it is softer thanintra-oral soft tissue, so as to form a soft cushion for bearing againstthe dental arch and dental structures of a patient.
 11. An orthodonticappliance according to claim 10, wherein the teeth engaging member ismade of a polymeric material that is silicone rubber.
 12. An orthodonticappliance according to claim 1, wherein the outer frame member isgenerally arch-shaped and the inner frame member is generallyarch-shaped so that the transverse spacing between the inner and outerframe members decreases from their free ends towards its front region,so that an outline shape of the base member corresponds substantiallywith that of the web of the teeth engaging member when viewed in planview.
 13. An orthodontic appliance according to claim 1, wherein the oneand the additional transverse frame members of the first pair have awidth of 1 to 4 mm, and the front transverse frame member has a width of8 to 12 mm.
 14. An orthodontic appliance according to claim 1, whereinthe base member further includes a second pair of transverse framemembers comprising a left rear transverse frame member towards one freeend of the base member, and a right rear transverse frame member towardsthe other free end of the base member.
 15. An orthodontic applianceaccording to claim 14, wherein the base member further includes a thirdpair of transverse frame members comprising a left transverse framemember positioned intermediate said transverse frame member of the firstpair towards one side edge of the front region, and the left reartransverse frame member, and a right transverse frame member positionedintermediate, said right transverse frame member of the first pairtowards the other side edge of the front region, and the right reartransverse frame member.
 16. An orthodontic appliance according to claim1, wherein the base member further includes a teeth row repositioningformation comprising an outer flange that projects up above the outerlongitudinal frame member.
 17. An orthodontic appliance according toclaim 16, wherein the outer flange includes a continuous wall on thecentral front region of the appliance that extends across the upperincisor teeth of a patient in use.
 18. An orthodontic applianceaccording to claim 17, wherein the continuous wall also extends alongthe left and right arm regions of the appliance that are aligned withsome of the molars of a use when the appliance is fitted to a patient.19. An orthodontic appliance according to claim 1, wherein the teethengaging member includes at least one pair of adjacent teeth positioningformations for assisting in positioning specific teeth that are adjacentto the teeth positioning formation along the line of the arch.
 20. Anorthodontic appliance according to claim 19, wherein each pair ofadjacent teeth positioning formations is aligned with each other alongthe length of the teeth engaging member and is located on respectivelythe inner and outer flanges of the teeth engaging member facing into theassociated teeth channel.
 21. An orthodontic appliance according toclaim 19, wherein each adjacent teeth positioning formation comprises awedge shaped protrusion having a wedge point facing into the channelaway from the flange on which it is located, and wherein eachpositioning formation is integrally formed with the flange on which itis located.
 22. An orthodontic appliance for promoting development of adental arch form in a patient who has an underdeveloped arch form, theappliance including: a base member that is made of a resilientlyflexible material having a shape that corresponds generally to a dentalarch form, the base member including: an open frame structure includinga curved outer frame member and a curved inner frame member that arespaced apart from each other; a first pair of transverse frame membersthat are aligned respectively with left and right outer incisors of apatient when the appliance is fitted to the patient; and a fronttransverse frame member intermediate the first pair of transverse framemembers; and a teeth engaging member that encloses at least part of thebase member and that defines at least one of upper and lower dental archreceiving channels, the teeth engaging member being made of aresiliently flexible material that is more flexible than the resilientlyflexible material of the base member and that can be deformed, whereinthe appliance comprises a front region and left and right arm regions oneither side of the front region, and the front region is formed with agreater stiffness than the left and right arm regions, and the appliancehas a resting form in which the resilient materials of the base memberand the teeth engaging member are in their resting condition, and whenthe appliance is deformed out of the resting form to fit theunderdeveloped dental arch form into the dental arch receiving channel,the greater stiffness of the front region enables it to exert a greaterreturn force against an anterior region of the dental arch form than thearm regions bearing against other regions of the dental arch form.
 23. Amethod of treating a patient to encourage development of a dental archform in a patient who has an underdeveloped arch form, said methodcomprising the steps of: fitting an orthodontic appliance in the mouthof the patient, said orthodontic appliance including: a base member thatis made of a resiliently flexible material having a shape thatcorresponds generally to a dental arch form, the base member including:an open frame structure including a curved outer frame member and acurved inner frame member that are spaced apart from each other; a firstpair of transverse frame members that are aligned respectively with leftand right outer incisors of a patient when the appliance is fitted tothe patient; and a front transverse frame member intermediate the firstpair of transverse frame members; and a teeth engaging member thatencloses at least part of the base member and that defines at least oneof upper and lower dental arch receiving channels, the teeth engagingmember being made of a resiliently flexible material that is moreflexible than the resiliently flexible material of the base member andthat can be deformed, wherein the appliance comprises a front region andleft and right arm regions on either side of the front region, and thefront region is formed with a greater stiffness than the left and rightarm regions, and the appliance has a resting form in which the resilientmaterials of the base member and the teeth engaging member are in theirresting condition, and when the appliance is deformed out of the restingform to fit the underdeveloped dental arch form into the dental archreceiving channel, the greater stiffness of the front region enables itto exert a greater return force against an anterior region of the dentalarch form than the arm regions bearing against other regions of thedental arch form, and having the patient wear the orthodontic applianceon a regular basis.
 24. The method according to claim 23, wherein saidstep of having the patient wear the appliance comprises wearing theappliance for at least 12 hours a day.
 25. The method according to claim23, further comprising the step of expanding the upper arch form totreat a step 2 malocclusion.
 26. The method according to claim 23,further comprising the step of aligning the dentition on theunderdeveloped dental arch of the patient.